Legend:
CC = Baltimore Convention Center, H = Hilton Baltimore
* = applied session ! = JSM meeting theme
Activity Details
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500 * !
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Wed, 8/2/2017,
10:30 AM -
12:20 PM
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CC-313
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Beyond Randomized Studies: Nonrandomized, Single Arm, or Special Studies — Topic Contributed Papers
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Section on Medical Devices and Diagnostics
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Organizer(s): Shiling Ruan, Novartis, Jie (Jack) Zhou, FDA/CDRH
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Chair(s): Ahn Chul, FDA/CDRH
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10:35 AM
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Why Not Consensus Reading with Multiple Readers for Evaluating a New (Test) Device?
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Bipasa Biswas, CDRH, FDA
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10:55 AM
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Confidence Interval Estimate of Success Rate on Correlated Data in a Single Arm Study
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Kate Wang, Allergan ; Richard Weng, Allergan ; Yijun Sun, Allergan
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11:15 AM
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A Bayesian Approach Developed for Single Arm Studies Using Performance Goals with Subgroups
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Wei-Chen Chen, FDA/CDRH ; Nelson Lu, CDRH/FDA
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11:35 AM
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Biomarker Based Study Design with Multiple Single Arms
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Shiling Ruan, Novartis
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11:55 AM
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Design and Analysis of Single Arm Clinical Trials Involving Highly Heterogeneous Subjects
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Sherry Liu, FDA
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12:15 PM
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Floor Discussion
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